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Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol (VITAKET)

Primary Purpose

Psoriasis Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ketokonazol 2% cream
UVB-radiation 311nm
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis vulgaris,, vitamin D, UVB-phototherapy, ketokonazol,, Optical Coherence Tomography,, local PASI, Nizoral

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age: 18- 80
  • diagnosis of psoriasis vulgaris (mild- middle)
  • no other current antipsoriatic therapy (systemic/topical)
  • at least 5 psoriatic areas of 5x5 cm

Exclusion Criteria:

  • pregnancy/nursing mothers
  • women in reproductive age without adequate contraception
  • severe and acute forms of psoriasis vulgaris
  • patients receiving systemic or topical antipsoroatic treatment in past 3 month
  • UV-therapy in past 3 month
  • patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma
  • epilepsy

Sites / Locations

  • Department of Dermatology, Medical Faculty, TU Dresden

Outcomes

Primary Outcome Measures

PASI, PGA

Secondary Outcome Measures

OCT/ultrasound- thickness of epidermis/ dermis

Full Information

First Posted
May 14, 2008
Last Updated
June 7, 2010
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00678756
Brief Title
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
Acronym
VITAKET
Official Title
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Psoriasis vulgaris,, vitamin D, UVB-phototherapy, ketokonazol,, Optical Coherence Tomography,, local PASI, Nizoral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ketokonazol 2% cream
Other Intervention Name(s)
Nizoral cream
Intervention Description
twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week
Intervention Type
Radiation
Intervention Name(s)
UVB-radiation 311nm
Other Intervention Name(s)
UVB Radiation, phototherapy, narrow-band ultraviolet B phototherapy
Intervention Description
3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm
Primary Outcome Measure Information:
Title
PASI, PGA
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
OCT/ultrasound- thickness of epidermis/ dermis
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age: 18- 80 diagnosis of psoriasis vulgaris (mild- middle) no other current antipsoriatic therapy (systemic/topical) at least 5 psoriatic areas of 5x5 cm Exclusion Criteria: pregnancy/nursing mothers women in reproductive age without adequate contraception severe and acute forms of psoriasis vulgaris patients receiving systemic or topical antipsoroatic treatment in past 3 month UV-therapy in past 3 month patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gottfried Wozel, Prof. Dr.med
Organizational Affiliation
Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Medical Faculty, TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol

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